Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in Japan

Background: The Japanese drug use system allowed the once-daily use of inhaled corticosteroid fluticasone furoate (FF) combined with a long-acting beta-2 agonist vilanterol (VI) and a long-acting muscarinic antagonist umeclidinium (UMEC) against asthma on 18 February 2021. We investigated the real-w...

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Main Authors: Akira Umeda, Hisato Shimada, Tateki Yamane, Taichi Mochizuki, Yasushi Inoue, Kenji Tsushima, Kazuya Miyagawa, Atsumi Mochida, Hiroshi Takeda, Yasumasa Okada, Katsunori Masaki, Masako Matsusaka, Koichi Fukunaga
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-04-01
Series:Frontiers in Physiology
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Online Access:https://www.frontiersin.org/articles/10.3389/fphys.2023.1131949/full
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author Akira Umeda
Akira Umeda
Hisato Shimada
Tateki Yamane
Taichi Mochizuki
Yasushi Inoue
Kenji Tsushima
Kazuya Miyagawa
Atsumi Mochida
Hiroshi Takeda
Yasumasa Okada
Katsunori Masaki
Masako Matsusaka
Koichi Fukunaga
author_facet Akira Umeda
Akira Umeda
Hisato Shimada
Tateki Yamane
Taichi Mochizuki
Yasushi Inoue
Kenji Tsushima
Kazuya Miyagawa
Atsumi Mochida
Hiroshi Takeda
Yasumasa Okada
Katsunori Masaki
Masako Matsusaka
Koichi Fukunaga
author_sort Akira Umeda
collection DOAJ
description Background: The Japanese drug use system allowed the once-daily use of inhaled corticosteroid fluticasone furoate (FF) combined with a long-acting beta-2 agonist vilanterol (VI) and a long-acting muscarinic antagonist umeclidinium (UMEC) against asthma on 18 February 2021. We investigated the real-world effects of these drugs (FF/UMEC/VI) mainly on lung function tests.Methods: This was an open-label, uncontrolled, within-group time-series (before-after) study. Prior asthma treatment (inhaled corticosteroid with/without a long-acting beta-2 agonist with/without a long-acting muscarinic antagonist) was switched to FF/UMEC/VI 200/62.5/25 μg. Subjects were evaluated by lung function tests prior to, and 1–2 months after, initiation of FF/UMEC/VI 200/62.5/25 μg. Patients were asked questions regarding the asthma control test and preference for drugs.Results: Overall, 114 asthma outpatients (97% Japanese) were enrolled from February 2021 to April 2022: 104 subjects completed the study. Forced expiratory volume in 1 s, peak flow, and asthma control test score of FF/UMEC/VI 200/62.5/25 μg-treated subjects were significantly increased (p < 0.001, p < 0.001, and p < 0.01, respectively). In contrast with FF/VI 200/25 μg, instantaneous flow at 25% of the forced vital capacity and expiratory reserve volume were significantly increased by FF/UMEC/VI 200/62.5/25 μg (p < 0.01, p < 0.05, respectively). Sixty-six percent of subjects declared they wanted to continue FF/UMEC/VI 200/62.5/25 μg in the future. Adverse effects, mainly local, were seen in 30% of patients, but no serious adverse effects were seen.Conclusion: Once-daily FF/UMEC/VI 200/62.5/25 μg was effective against asthma without serious adverse events. This is the first report that demonstrated FF/UMEC/VI dilated peripheral airways using lung function tests. This evidence on drug effects may improve our understanding of pulmonary physiology and the pathophysiology of asthma.
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spelling doaj.art-66facbfbe41d444cac8bd9321c328d062023-05-11T11:20:30ZengFrontiers Media S.A.Frontiers in Physiology1664-042X2023-04-011410.3389/fphys.2023.11319491131949Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in JapanAkira Umeda0Akira Umeda1Hisato Shimada2Tateki Yamane3Taichi Mochizuki4Yasushi Inoue5Kenji Tsushima6Kazuya Miyagawa7Atsumi Mochida8Hiroshi Takeda9Yasumasa Okada10Katsunori Masaki11Masako Matsusaka12Koichi Fukunaga13Department of General Medicine, School of Medicine, International University of Health and Welfare (IUHW), IUHW Shioya Hospital, Yaita, JapanDepartment of Respiratory Medicine, IUHW Shioya Hospital, Yaita, JapanDepartment of Respiratory Medicine, IUHW Shioya Hospital, Yaita, JapanDepartment of Digestive Organ, IUHW Shioya Hospital, Yaita, JapanRespiratory Diseases Center, IUHW Mita Hospital, Tokyo, JapanRespiratory Diseases Center, IUHW Mita Hospital, Tokyo, JapanDepartment of Pulmonary Medicine, School of Medicine, International University of Health and Welfare, Narita, JapanDepartment of Pharmacology, School of Pharmacy, International University of Health and Welfare, Otawara, JapanDepartment of Pharmacology, School of Pharmacy, International University of Health and Welfare, Otawara, JapanDepartment of Pharmacology, School of Pharmacy at Fukuoka, International University of Health and Welfare, Fukuoka, JapanDepartment of Internal Medicine, National Hospital Organization Murayama Medical Center, Musashimurayama, JapanDivision of Pulmonary Medicine, Department of Medicine, Keio University, Tokyo, JapanDivision of Pulmonary Medicine, Department of Medicine, Keio University, Tokyo, JapanDivision of Pulmonary Medicine, Department of Medicine, Keio University, Tokyo, JapanBackground: The Japanese drug use system allowed the once-daily use of inhaled corticosteroid fluticasone furoate (FF) combined with a long-acting beta-2 agonist vilanterol (VI) and a long-acting muscarinic antagonist umeclidinium (UMEC) against asthma on 18 February 2021. We investigated the real-world effects of these drugs (FF/UMEC/VI) mainly on lung function tests.Methods: This was an open-label, uncontrolled, within-group time-series (before-after) study. Prior asthma treatment (inhaled corticosteroid with/without a long-acting beta-2 agonist with/without a long-acting muscarinic antagonist) was switched to FF/UMEC/VI 200/62.5/25 μg. Subjects were evaluated by lung function tests prior to, and 1–2 months after, initiation of FF/UMEC/VI 200/62.5/25 μg. Patients were asked questions regarding the asthma control test and preference for drugs.Results: Overall, 114 asthma outpatients (97% Japanese) were enrolled from February 2021 to April 2022: 104 subjects completed the study. Forced expiratory volume in 1 s, peak flow, and asthma control test score of FF/UMEC/VI 200/62.5/25 μg-treated subjects were significantly increased (p < 0.001, p < 0.001, and p < 0.01, respectively). In contrast with FF/VI 200/25 μg, instantaneous flow at 25% of the forced vital capacity and expiratory reserve volume were significantly increased by FF/UMEC/VI 200/62.5/25 μg (p < 0.01, p < 0.05, respectively). Sixty-six percent of subjects declared they wanted to continue FF/UMEC/VI 200/62.5/25 μg in the future. Adverse effects, mainly local, were seen in 30% of patients, but no serious adverse effects were seen.Conclusion: Once-daily FF/UMEC/VI 200/62.5/25 μg was effective against asthma without serious adverse events. This is the first report that demonstrated FF/UMEC/VI dilated peripheral airways using lung function tests. This evidence on drug effects may improve our understanding of pulmonary physiology and the pathophysiology of asthma.https://www.frontiersin.org/articles/10.3389/fphys.2023.1131949/fullasthmafluticasone furoatevilanterolumeclidiniumsmall airwaysperipheral airways
spellingShingle Akira Umeda
Akira Umeda
Hisato Shimada
Tateki Yamane
Taichi Mochizuki
Yasushi Inoue
Kenji Tsushima
Kazuya Miyagawa
Atsumi Mochida
Hiroshi Takeda
Yasumasa Okada
Katsunori Masaki
Masako Matsusaka
Koichi Fukunaga
Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in Japan
Frontiers in Physiology
asthma
fluticasone furoate
vilanterol
umeclidinium
small airways
peripheral airways
title Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in Japan
title_full Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in Japan
title_fullStr Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in Japan
title_full_unstemmed Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in Japan
title_short Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in Japan
title_sort real world effects of once daily inhaled steroid fluticasone furoate combined with long acting beta 2 agonist vilanterol and long acting muscarinic antagonist umeclidinium on lung function tests of asthma patients in japan
topic asthma
fluticasone furoate
vilanterol
umeclidinium
small airways
peripheral airways
url https://www.frontiersin.org/articles/10.3389/fphys.2023.1131949/full
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